Intuitive Surgical Inc., maker of the Da Vinci Surgical Robot broke procedures when it warned patients and surgeons about problems with the robot without first alerting regulators. The FDA noted four observations in a Form 483 letter following inspections at Intuitive’s facility.
The Form 483 is a notice that informs a company about possible violation(s) of federal regulations that are found by FDA inspectors. These are inspection observations and do not represent a final determination by the agency regarding compliance.
The FDA noted in its observations that a correction conducted by Intuitive to reduce the health risks posed by its devices was not reported in writing to the agency. According to the FDA, on October 10, 2011 Intuitive notified patients about “suggestions and recommendations for the proper use of instruments with tip coverage and for the correct generators that should be used with mono-polar instruments.” This was not reported to the San Francisco District Recall Coordinator. This notice was in response to the 134 complaints and 82 filed Medical Device Reporting, or MDRs, related to tip cover issues.
On October 13, 2011, the FDA noted that Intuitive sent another letter to da Vinci Surgical Robot clients informing them that the devices were not cleared for thyroidectomy indication. However, the company did not report this to the regulator. The agency noted that Intuitive received 13 complaints and filed five MDRs related to thyroidectomy performed with the devices.
Intuitive sent another letter to da Vinci clients on October 17, 2011 with information on the proper flushing of instruments, the proper transportation of the da Vinci between buildings and inspecting instrument cannulas. This information was also not reported to the San Francisco District Recall Coordinator.
Intuitive also did not report injuries or illnesses that occurred with the use of correctable devices. This includes the five MDRs associated with the action taken on October 13.
In addition, Intuitive did not establish procedures for design changes. They did not document the decision to add thyroidectomy indication to the da Vinci system general laparoscopy clearance. At the time there was no procedure in place to document this, but on April 2, 2012 there was a procedure.
Finally, Intuitive failed to adequately document design input requirements. The intrasurgical cleaning of surgical instruments was not part of the user needs included with the robot. However, the design of surgical instruments is commonly known to need cleaning during surgery.
With all of these observations, the San Francisco District Recall Coordinator was never notified.
These observations are essential for the use of the da Vinci Robot manufactured by Intuitive Surgical, Inc. As patients we trust our physicians to do the right thing. We also trust the companies who produce products to uphold certain standards that keep us safe. When information is not released to the FDA about an issue like this, serious complications arise. If you or a loved one had surgery performed by a da Vinci Robot and may be injured please call us for a free consultation. Justice can be sought and no innocent person deserves to be injured.
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